6550--596-24-3-025-0016 - pylarify contract - 6/15/24 - 06/14/29

Closed Solicitation Posted

Solicitation number
36C24924Q0169
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Notice details come from SAM.gov. Updated .

About this opportunity

The Department of Veterans Affairs, Veterans Health Administration, Veterans Integrated Service Network 9 is issuing a solicitation for an Indefinite Delivery Indefinite Quantity (IDIQ) contract to provide radiopharmaceuticals to the Lexington VA Medical Center. The contractor will be required to deliver radiopharmaceuticals that meet specific technical requirements, including minimum half-life and resolution criteria, and comply with all applicable federal regulations. Offerors must submit pricing, past performance, and technical capability information, which will be evaluated on a best value basis. The contract has a 5-year period of performance with 5 one-year ordering periods.

This is a small business set-aside solicitation. The contract will be awarded to the responsible offeror whose quote is most advantageous to the government, considering technical, past performance, and price factors. The estimated quantities are based on one year's usage, but may vary depending on patient demand. The radiopharmaceuticals must be delivered at least 30 minutes prior to the dose calibration time, with any recalled or incorrectly delivered doses credited to the government.

Notice text

3 versions

Update #3 · Latest ·

36C24924Q0169

Page 1 of

Page 60 of 60

Page 1 of

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (SEP 2023)

(a) North American Industry Classification System (NAICS) code and small business size standard. The NAICS code(s) and small business size standard(s) for this acquisition appear elsewhere in the solicitation. However, the small business size standard for a concern that submits an offer, other than on a construction or service acquisition, but proposes to furnish an end item that it did not itself manufacture, process, or produce is 500 employees, or 150 employees for information technology value-added resellers under NAICS code 541519, if the acquisition

(1) Is set aside for small business and has a value above the simplified acquisition threshold;

(2) Uses the HUBZone price evaluation preference regardless of dollar value, unless the offeror waives the price evaluation preference; or

(3) Is an 8(a), HUBZone, service-disabled veteran-owned, economically disadvantaged women-owned, or women-owned small business set-aside or sole-source award regardless of dollar value.

(b) Submission of offers. Submit signed and dated offers to the office specified in this solicitation at or before the exact time specified in this solicitation. Offers may be submitted on the SF 1449, letterhead stationery, or as otherwise specified in the solicitation. As a minimum, offers must show

(1) The solicitation number;

(2) The time specified in the solicitation for receipt of offers;

(3) The name, address, and telephone number of the offeror;

(4) A technical description of the items being offered in sufficient detail to evaluate compliance with the requirements in the solicitation. This may include product literature, or other documents, if necessary;

(5) Terms of any express warranty;

(6) Price and any discount terms;

(7) "Remit to" address, if different than mailing address;

(8) A completed copy of the representations and certifications at Federal Acquisition Regulation (FAR) 52.212-3 (see FAR 52.212-3(b) for those representations and certifications that the offeror shall complete electronically);

(9) Acknowledgment of Solicitation Amendments;

(10) Past performance information, when included as an evaluation factor, to include recent and relevant contracts for the same or similar items and other references (including contract numbers, points of contact with telephone numbers and other relevant information); and

(11) If the offer is not submitted on the SF 1449, include a statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation. Offers that fail to furnish required representations or information, or reject the terms and conditions of the solicitation may be excluded from consideration.

(c) Period for acceptance of offers. The offeror agrees to hold the prices in its offer firm for 30 calendar days from the date specified for receipt of offers, unless another time period is specified in an addendum to the solicitation.

(d) Product samples. When required by the solicitation, product samples shall be submitted at or prior to the time specified for receipt of offers. Unless otherwise specified in this solicitation, these samples shall be submitted at no expense to the Government, and returned at the sender's request and expense, unless they are destroyed during preaward testing.

(e) Multiple offers. Offerors are encouraged to submit multiple offers presenting alternative terms and conditions, including alternative line items (provided that the alternative line items are consistent with FAR subpart 4.10), or alternative commercial products or commercial services for satisfying the requirements of this solicitation. Each offer submitted will be evaluated separately.

(f) Late submissions, modifications, revisions, and withdrawals of offers.

(1) Offerors are responsible for submitting offers, and any modifications, revisions, or withdrawals, so as to reach the Government office designated in the solicitation by the time specified in the solicitation. If no time is specified in the solicitation, the time for receipt is 4:30 p.m., local time, for the designated Government office on the date that offers or revisions are due.

(2)(i) Any offer, modification, revision, or withdrawal of an offer received at the Government office designated in the solicitation after the exact time specified for receipt of offers is "late" and will not be considered unless it is received before award is made, the Contracting Officer determines that accepting the late offer would not unduly delay the acquisition; and

(A) If it was transmitted through an electronic commerce method authorized by the solicitation, it was received at the initial point of entry to the Government infrastructure not later than 5:00 p.m. one working day prior to the date specified for receipt of offers; or

(B) There is acceptable evidence to establish that it was received at the Government installation designated for receipt of offers and was under the Government's control prior to the time set for receipt of offers; or

(C) If this solicitation is a request for proposals, it was the only proposal received.

(ii) However, a late modification of an otherwise successful offer, that makes its terms more favorable to the Government, will be considered at any time it is received and may be accepted.

(3) Acceptable evidence to establish the time of receipt at the Government installation includes the time/date stamp of that installation on the offer wrapper, other documentary evidence of receipt maintained by the installation, or oral testimony or statements of Government personnel.

(4) If an emergency or unanticipated event interrupts normal Government processes so that offers cannot be received at the Government office designated for receipt of offers by the exact time specified in the solicitation, and urgent Government requirements preclude amendment of the solicitation or other notice of an extension of the closing date, the time specified for receipt of offers will be deemed to be extended to the same time of day specified in the solicitation on the first work day on which normal Government processes resume.

(5) Offers may be withdrawn by written notice received at any time before the exact time set for receipt of offers. Oral offers in response to oral solicitations may be withdrawn orally. If the solicitation authorizes facsimile offers, offers may be withdrawn via facsimile received at any time before the exact time set for receipt of offers, subject to the conditions specified in the solicitation concerning facsimile offers. An offer may be withdrawn in person by an offeror or its authorized representative if, before the exact time set for receipt of offers, the identity of the person requesting withdrawal is established and the person signs a receipt for the offer.

(g) Contract award (not applicable to Invitation for Bids). The Government intends to evaluate offers and award a contract without discussions with offerors. Therefore, the offeror's initial offer should contain the offeror's best terms from a price and technical standpoint. However, the Government reserves the right to conduct discussions if later determined by the Contracting Officer to be necessary. The Government may reject any or all offers if such action is in the public interest; accept other than the lowest offer; and waive informalities and minor irregularities in offers received.

(h) Multiple awards. The Government may accept any item or group of items of an offer, unless the offeror qualifies the offer by specific limitations. Unless otherwise provided in the Schedule, offers may not be submitted for quantities less than those specified. The Government reserves the right to make an award on any item for a quantity less than the quantity offered, at the unit prices offered, unless the offeror specifies otherwise in the offer.

(i) Availability of requirements documents cited in the solicitation.

(1)(i) The GSA Index of Federal Specifications, Standards and Commercial Item Descriptions, FPMR Part 101-29, and copies of specifications, standards, and product descriptions can be downloaded from the ASSIST website at https://assist.dla.mil.

(ii) If the General Services Administration, Department of Agriculture, or Department of Veterans Affairs issued this solicitation, a copy of specifications, standards, and commercial item descriptions cited in this solicitation may be obtained from the address in paragraph (i)(1)(i) of this provision.

(2) Most unclassified Defense specifications and standards may be downloaded from the ASSIST website at https://assist.dla.mil.

(3) Defense documents not available from the ASSIST website may be requested from the Defense Standardization Program Office by-

(i) Using the ASSIST feedback module (https://assist.dla.mil/feedback); or

(ii) Contacting the Defense Standardization Program Office by telephone at 571-767-6688 or email at assisthelp@dla.mil.

(4) Nongovernment (voluntary) standards must be obtained from the organization responsible for their preparation, publication, or maintenance.

(j) Unique entity identifier. (Applies to all offers that exceed the micro-purchase threshold, and offers at or below the micro-purchase threshold if the solicitation requires the Contractor to be registered in the System for Award Management (SAM).) The Offeror shall enter, in the block with its name and address on the cover page of its offer, the annotation Unique Entity Identifier followed by the unique entity identifier that identifies the Offeror s name and address. The Offeror also shall enter its Electronic Funds Transfer (EFT) indicator, if applicable. The EFT indicator is a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the Offeror to establish additional SAM records for identifying alternative EFT accounts (see FAR subpart 32.11) for the same entity. If the Offeror does not have a unique entity identifier, it should contact the entity designated at www.sam.gov for unique entity identifier establishment directly to obtain one. The Offeror should indicate that it is an offeror for a Government contract when contacting the entity designated at www.sam.gov for establishing the unique entity identifier.

(k) [Reserved]

(l) Debriefing. If a post-award debriefing is given to requesting offerors, the Government shall disclose the following information, if applicable:

(1) The agency's evaluation of the significant weak or deficient factors in the debriefed offeror's offer.

(2) The overall evaluated cost or price and technical rating of the successful and the debriefed offeror and past performance information on the debriefed offeror.

(3) The overall ranking of all offerors, when any ranking was developed by the agency during source selection.

(4) A summary of the rationale for award;

(5) For acquisitions of commercial products, the make and model of the product to be delivered by the successful offeror.

(6) Reasonable responses to relevant questions posed by the debriefed offeror as to whether source-selection procedures set forth in the solicitation, applicable regulations, and other applicable authorities were followed by the agency.

(End of Provision)

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

This request for quotes is issued IAW FAR Parts 12 and 13.

Comparative evaluations of quotes will be performed in accordance with FAR 13.106-2(b), best value based on price and other factors.

This RFQ will result in one firm-fixed price Indefinitely Delivery Indefinite Quantity contract.

SUBMISSION REQUIREMENTS

Pricing

Quoting firms shall submit a pricing schedule that shows unit and Line Item total prices for all equipment and all labor IAW the SOW found at Section B.2 of this solicitation. Pricing shall include a final tally of project price. Quotes that do not include a final tally of project price will be determined to be non-responsive.

Past performance information

Quoting firms shall submit three references for past contracts. Past performance information shall include:

Customer

Annual and total project price

Number of doses

Dates of contract period of performance

Associated contract number (if USG project)

Customer Point of contact information, to include name, email address, and phone number.

Past Performance Narratives are limited to one page per project, 12-point Times New Roman font, with one-inch margins top, bottom, and sides, on either Microsoft Word or Adobe PDF documents.

Technical Capability

Radiopharmaceutical/Item Capability

In accordance with FAR 11.104, this is a Brand Name or Equal purchase description. The salient physical, functional, and performance characteristics are detailed at section B.2 of the Statement of Work. Quoting firms shall provide the salient characteristics of radiopharmaceutical information and must include the following information:

Half-life of the proposed radiopharmaceutical.

Resolution of the proposed radiopharmaceutical.

Radiopharmacy Certifications

Quoting firms shall submit evidence of firm s business socio economic status, DUNS, UEI, and SAM registration.

Contractor shall provide proof that they meet all Nuclear Regulatory Commission, Department of Transportation, FDA, OSHA, and all other State and Federal rules and regulations.

Proposed Personnel Qualifications

RADIOPHARMACY PERSONNEL: Quoting firms shall submit the contemplated Support Personnel qualifications on a one-page document, 12-point Times New Roman, MS Word or Adobe PDF, clearly describing the individual s education, training, licensure, and certification. One page per contemplated support individual.

DELIVERY PERSONNEL: Contractor shall provide evidence of special driver s licenses required for transporting hazardous materials.

QUESTIONS

Questions pertaining to this solicitation are due NLT 9 a.m., CST, June 12, 2024, in writing only, to Contract Specialist Phon Phasavath at Phon.phasavath@va.gov. Any questions received will be compiled, answered, and posted via an amendment to this solicitation.

Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following provisions are incorporated into 52.212-1 as an addendum to this solicitation:

E.2 52.212-2 EVALUATION COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)

(a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

Price

The Government will evaluate more highly the cumulative lowest priced quote.

Past Performance

Quoting firms shall submit past performance information in accordance with the requirements of 52.212-1 Addendum: Submission Requirements.

The Government will evaluate more highly quoting firms with past performance information of successfully completing contracts of similar size and scope at other Veterans Affairs Medical facilities.

The Government will evaluate more highly quoting firms with past performance information of successfully completing contracts of similar size and scope at other medical facilities with similar size and complexity to that of Lexington VA Medical Center.

The Government will evaluate more highly past performance references with CPARS ratings of Very Good or higher.

Technical Capability

Radiopharmaceutical/Item Capability

This factor will be evaluated as a Go/No-go. The item capability will be evaluated per the salient physical, functional, and performance characteristics are detailed at section B.2 of the Statement of Work.

Radiopharmacy Certification

The Government will evaluate the responding firm s submitted documentation providing proof that all stated rules and regulations are met. This is Go/NO-go factor.

Proposed Personnel Qualifications

The Government will evaluate more highly qualifications for supporting personnel certifications per page 35 Addendum to FAR 52.212-1 (3) (c)(i)(ii). This is a Go/No-go factor.

(b) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

(End of Provision)

Update #2 ·

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Update #1 ·

STATEMENT OF WORK

1

Delivery/Scope: Quantities expressed in the schedule are estimates based on usage for one year. Quantities may vary based on patient demand. The term of this agreement will be for five years.

All Radiopharmaceuticals are to be furnished by the Contractor in strict accordance with the terms and conditions of the contract and all applicable local, State and Federal Laws.

Contractor/Supplier shall abide by (CFR 10) Title Code of Federal Regulations, which states: A licensee may use for medical use only:

By-product material manufactured, labeled, packaged and distributed in accordance with a license issued pursuant to the regulations in Tile 10, Code of Feral Regulations, Part 35 and the equivalent regulations of an Agreement State.

All routine orders for radiopharmaceuticals shall be placed as needed by the Nuclear Medicine Staff at by 3:00 PM EST the day prior to the patient study date and delivered for the specified dates and times. It is understood that orders for the next day must be placed with the Pharmacy by 3:00pm, and that radiopharmaceuticals are only available for delivery Monday-Friday. It is understood that doses ordered for the same day delivery will be supplied based on product availability and mutual agreement only.

The Contractor will ensure that all radiopharmaceutical doses are delivered at least 30 minutes prior to the dose calibration time.

Patients last name only will be entered in the Contractors Web site or via telephone to reserve a dose.

C&A requirements do not apply, and a Security Accreditation Package is not required.

The first delivery shall be made to Nuclear Medicine (Room A-152a) depending on product availability at minimum 30 minutes before the calibration time unless prior authorization arrangements have been made. Delivery shall be made directly to a Nuclear Medicine Technologists on duty, Deliveries before 6:00am shall be made by contacting the VA Police Department located on the first floor to unlock the Nuclear Medicine Department Night Entry (Room A-152A) for placement of the packages.

Delivery personnel shall be bonded by the Contractor.

Contractor shall provide evidence of special driver s licenses required for transporting hazardous materials, and the couriers must be wearing identification tags upon enter the VA.

Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, FDA, OSHA, and all other State and Federal rules and regulations.

All radiopharmaceuticals shall be delivered in proper shielded containers with disposal impenetrable biohazard liners. Shipping containers and their labeling must comply with all federal and state regulations.

Contractor will provide a packing list which provides a Description product code, activity amount, Calibration date/time, Expiration date/time, volume, Qty, Rx # with each delivery.

All unit dose radiopharmaceuticals delivered must have a bar code for scanning into a dose tracking system.

Radiopharmaceutical must have a minimum half-life of 90 minutes due to possible delay of the Veteran patient s arrival for their appointment.

Radiopharmaceutical resolution must have a median contrast to noise ratio of 20% or greater.

Any recalled / incorrectly delivered dose for any reason shall be credited for the full amount.

If the ordered Radiopharmaceutical is not available and cannot be delivered to the VA when needed, the Contractor will notify the VA Nuclear Medicine Department 859-381-5927 by 8:00am local time and will not bill the customer.

Customer must notify contractor_________________ by _________am/pm local standard time on the day of the patient s study to cancel an order or the customer shall be responsible for the payment.

Incorrectly delivered doses shall not exceed one per month.

Any doses deemed below standard by the facility shall be credited toward the account and shall not exceed two per year.

Federal Holidays will be observed, and the Nuclear Medicine Department will be closed on the days listed below:

- New Year s Day

- Martin Luther King s Birthday

- Presidents Day

- Memorial Day

- Juneteenth

- Independence Day

- Columbus Day

- Veterans Day

- Thanksgiving

- Christmas Day

- Any other day declared a Federal Holiday by the US President.

Contractor shall provide any additional technical support deemed necessary for the technical staff, physicians at no charge to the Government.

Radiopharmaceuticals shall be calibrated and labeled with concentration, calibration time, total volume, total activity and expiration time and date.

The radiopharmaceutical shall be USP compliant for sterile compounding and shall provide a statement to this effect.

Product information including suppliers source of radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier s license and procedures shall be provided upon request at no additional charge.

Consultation services regarding radiopharmaceutical applications, problems, controls, etc., shall be provided upon request at no charge.

Personnel authorized to place orders: The following personnel are authorized to telephone and or fax radiopharmaceutical orders:

Supervisory Nuclear Medicine Technologist

Nuclear Medicine / PET Technologist

Other Lexington VA Medical Staff as designated

Invoicing

Contracting Officer Representative (COR) shall be provided with a copy of the invoice at the end of each month for approval before submission to the Contract Radiopharmacy s Business Center for processing. Invoices shall be submitted electronically for approval to: Jennifer.Coffey@va.gov

Said invoices will be reviewed by the COR for accuracy and any discrepancies corrected and a new invoice sent before invoice is finalized. All invoices will include the following

Name and address of the Contractor

Invoice date and purchase order number

Contact number or PO#

An itemized listing of charges.

Invoices are to be submitted by the contractor to the Invoice Processing Payment System for payment.

Contractor shall be paid monthly, in arrears, upon a submission of a properly prepared invoice for services / supplies during the period.

Payment is to be made to:

Contractor:________________________

________________________

________________________

________________________

Performance/Quality

Incorrectly delivered doses shall not exceed one per month.

Any doses deemed below standard by the facility shall be credited toward the account and shall not exceed one per quarter, i.e. 4 per year.

It is the offerors responsibility to provide the VA with recall notices on any product that has been delivered to the VA that may be defective. Notification shall be made to the Contracting Officer Representative via the most expedient method.

Contractor shall provide complete documentation of quality control results upon request. Product information including suppliers source of radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier s license and procedures shall be provided at no additional charge.

Offeror will perform quality control on each agent dispensed. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies. Only those products that pass quality control may be sent to the VA Nuclear Medicine Service. The supplier will demonstrate documentation of quality control performance of any item upon request of the VA Nuclear Medicine Service.

All products are purchased subject to acceptance by the VA Nuclear Medicine Service. Products that fail to meet quality control criteria of Nuclear Medicine will not be accepted. Products will be rejected and may be discarded if found unsatisfactory by the Nuclear Medicines quality control when they are received, or later if deterioration of the product occurs before the expiration date. The VA will not be financially liable for unacceptable materials.

Qualifications: Personnel assigned by the contractor to perform the services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by VA Facility Director.

Personnel Policy: The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the contractor shall provide the following for those personnel: workers compensation professional liability insurance, health examinations, income tax withholding and Social Security payments. Such personnel shall not be considered VA employees for any purpose and shall be considered employees of the contractor.

Files

File Type Posted
36C24924Q0169 0002.docx DOCX document
36C24924Q0169 0001.docx DOCX document
36C24924Q0169_1.docx DOCX document

Notice history

Notice Type Posted
This notice Latest solicitation Solicitation
6550--596-24-3-025-0016 - pylarify contract - 6/15/24 - 06/14/29 Original Special Notice

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